COVIDMED - An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients

Daniel Freilich; Jennifer Victory; Paul Jenkins; Anne Gadomski

doi:10.1016/j.conctc.2022.100968

COVIDMED - An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients

Contemp Clin Trials Commun. 2022 Oct:29:100968. doi: 10.1016/j.conctc.2022.100968. Epub 2022 Jul 20.

Authors

Daniel Freilich¹, Jennifer Victory², Paul Jenkins², Anne Gadomski²

Affiliations

¹ Bassett Medical Center, 1 Atwell Rd, Cooperstown, NY, 13326, USA.
² Bassett Research Institute, 1 Atwell Rd, Cooperstown, NY, 13326, USA.

Abstract

Objectives: To assess the efficacy and safety of losartan for COVID-19 patients.

Methods: COVIDMED was a double-blinded, placebo-controlled platform RCT. Enrollees were randomized to standard care plus hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo. Hydroxychloroquine and lopinavir/ritonavir arms were discontinued early. We report losartan data vs. combined (lopinavir-ritonavir and placebo) and prespecified placebo-only controls. The primary endpoint was the mean COVID-19 Ordinal Severity Score (COSS) slope of change. Slow enrollment prompted early termination.

Results: Fourteen patients were included in our final analysis (losartan [N = 9] vs. control [N = 5] [lopinavir/ritonavir [N = 2], placebo [N = 3]]). Most baseline parameters were balanced. Losartan treatment was not associated with a difference in mean COSS slope of change vs. combined (p = 0.4) or placebo-only control (p = 0.05) (trend favoring placebo). 60-day mortality and overall AE/SAE rates were insignificantly higher with losartan.

Conclusion: In this small RCT in hospitalized COVID-19 patients, losartan did not improve outcome and was associated with adverse safety signals.

Keywords: Angiotensin II receptor Blocker (ARB); Angiotensin converting enzyme inhibitor (ACEi); COSS, COVID-19 Ordinal Severity Score; COVID-19; Losartan; Randomized clinical trial (RCT); SARS-CoV-2.